This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

Use:

This device is a vertebral body replacement device that is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma (that is, a fracture).

Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.

Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon.

For more information, see Useful Links below.

FDA District:

Philadelphia

FDA Comments:

Hospitals and surgeons that have these recalled devices must stop implanting them immediately.

On September 23, 2009, the company notified hospitals and sales consultants about this recall by mail. The company:

identified the recalled product

described the problem and potential health effects

provided instructions to their customers to return all products in their inventory and all surgically removed devices for evaluation.

notified and provided instructions to physicians and patients (through their physicians)

On November 09, 2009, the company sent physicians a follow up letter for their patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.